Optimizing the Efficiency and Implementation of Cash Transfers to Improve Adherence to Antiretroviral Therapy Phase II (Afya 2 Phase2)

University of California (UC), Berkeley

Status: Completed

Conditions: HIV (Human Immunodeficiency Virus)

Treatments: Behavioral: Conditional Cash Transfer

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT04201353

R01MH112432-01A2

Details and patient eligibility

About

This protocol describes a 2-arm cluster, randomized controlled trial designed to test the effectiveness of a conditional cash transfer on viral suppression at 12 months post-ART initiation among PHWHIV who have initiated ART within the past 30 days. Randomization will take place at the clinic level (HIV primary care clinics), and eligible participants attending intervention clinics will have the opportunity to receive up to 6 consecutive monthly cash transfers of 22,500 TSH (~$10) each, conditional on visit attendance with the HIV care provider. The study will take place at 32 clinics across four regions in Tanzania: Gaeta, Mwanza, Kagera and Shinyanga. The primary endpoint is viral suppression at 12 months, defined as the proportion of people living with HIV (PLHIV) retained in HIV primary care and with suppressed HIV viral load 12 months after starting ART.

Enrollment: 1,984 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Greater than or equal to 18 years of age
• Living with HIV infection
• Initiated on antiretroviral therapy less than or equal to 1 month prior to enrollment in the study
• Have access to a mobile phone (ownership, shared ownership, or access to a trusted person's phone)
• Do not intend to transfer to a different facility for HIV care within the following 12 months.

Exclusion criteria

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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1,984 participants in 2 patient groups

Conditional Cash Transfer

Experimental group

Description:

Participants attending intervention clinics will have the opportunity to receive up to 6 consecutive monthly cash transfers of 22,500 TSH (\~$10) each, conditional on visit attendance with the HIV care provider. Cash transfers will be given once monthly for up to 6 months, spaced ≥25 days apart (consistent with National Guidelines for monthly or bimonthly visits) and are conditional on visit attendance. This means that the cash transfer is only given when the patient visits the clinic for their routine appointment, regardless of whether the visit is earlier or later than the scheduled appointment.

Treatment:

Behavioral: Conditional Cash Transfer

Control

No Intervention group

Description:

Participants attending control clinics will receive the standard of care.